Abstract
Human subject protection training is required for all research personnel regardless of funding source. This article summarizes recommendations from a discussion about ethics training for community personnel from the practice-based research network (PBRN) listserv sponsored by the Agency for Health Care Research and Quality PBRN Resource Center. PBRN projects can involve community providers and their staff as subjects of the research project or as collaborators with recruitment and data collection. Distinguishing between usual care and research procedures is important for determining if training is required of community-based personnel. The use of research assistants or practice facilitators to collect research-related information is one way of limiting practice involvement to usual care procedures, thereby allowing PBRNs to limit training to dedicated research staff. Key methodologies for human subject protection training of community practice staff include on-site lectures, online modules, videotapes, and paper-based training. Ultimately, a discussion by the PBRN researcher with his or her governing Institutional Review Board is recommended for finding acceptable strategies within a PBRN.
New practice-based research networks (PBRNs) face a variety of operational challenges when starting projects within the community practice setting. Such challenges include hiring and training research assistants, practice recruitment, training providers and staff, determining staff availability for study procedures, finding space to conduct study interviews, and patient recruitment and retention. Compared with single-site, academic-based projects, implementation of community-based studies requires extra planning, attention to relationships, and adaptability.1 One of the most difficult operational challenges for PBRNs is ensuring appropriate yet efficient human subjects protection (HSP) for their research. Newly established network investigators and coordinators can benefit from mentoring by or networking with their more experienced counterparts in confronting these challenges.
The Agency for Health Care Research and Quality (AHRQ) PBRN listserv is a venue for communication available to registered members. Practice-based networks with at least 15 clinicians or practices and composed of more than 50% primary care clinicians are eligible to register with the AHRQ PBRN Resource Center.2 Registration is free, and the registry contains 35 questions pertaining to design, size, and geography of the network, the types of research conducted within the network, and staff contact information. Although primarily used for sending announcements to the group, individual members can pose questions or solicit advice for any issue pertaining to practice-based research. This article reports an example encountered by the Northern States Ambulatory Research Network PBRN, located in North Dakota, regarding the training of community personnel on HSP. The discussion thread contains advice from experienced PBRN members and insights into the different approaches used to satisfy the Institutional Review Board (IRB) training requirement.
Results
The listserv discussion is shown in Table 1. All respondents have agreed to have their responses published and were provided the opportunity to review and edit their comments.
PBRN Resource Center Listserv Discussion
Discussion
PBRNs are “disruptive innovations,”3 challenging research orthodoxy and expanding the horizons of the research enterprise. PBRNs evolve to meet the nation's health care challenges as the need for sophisticated translational research grows4 and distinctions between research and quality improvement blur.5 Best practices research, clinical demonstration projects, learning collaboratives, quality improvement organizations, and regional health information exchange organizations are increasingly under the contradictory pressures of having to prove and share their effectiveness in ways that look more and more like research, and having to abide by increasingly stringent HSP regulation. The recent controversy regarding IRB oversight of a quality improvement project using intensive care unit checklists is but one highly visible example of the confusion engendered by these contradictory pressures.6 The challenge for PBRNs is to continue to create new knowledge to improve peoples’ health while ensuring adequate protection of participants who are potentially at risk in this difficult environment.
The use of an electronic mail forum to pose questions and receive advice from PBRN leaders is one method of learning from the experiences of others who have faced similar dilemmas. In this example, investigators involved in the design and conduct of studies based within the community setting are required to understand the issues regarding HSP training for clinicians and staff. Investigators must understand which protocol designs require clinician HSP training, the pertinent HSP content that should be covered, permissible methods for delivering training, and specific local IRB requirements. Common themes that were discussed in the AHRQ PBRN listserv are highlighted below.
Does my Protocol Require HSP Training of Community Practitioners and Their Staff?
The US Office of Human Research Protection requires that “key personnel,” defined as “all individuals responsible for the design and conduct of the study,” complete HSP training.7 Given the constraints of a busy primary care practice, PBRN researchers are careful to delineate the roles of everyone involved for each study protocol. Responsibilities may include recruitment, informed consent, study intervention, survey completion, follow-up, and data entry.8 In some studies, such as those in which the clinicians and staff are either the subjects of the study or are solely required to continue with procedures that are considered part of usual care, most of the research responsibilities can be conducted by a research assistant who has completed the required HSP and study procedure training. However, in some situations Health Insurance Portability and Accountability Act (HIPAA) regulations may prevent the efficient collection of data by research assistants who would not otherwise have access to patients’ protected health information (PHI). However, other study protocols may require the office staff or providers to identify eligible patients, recruit these potential participants, obtain informed consent, offer the study intervention, fill out study-related forms, and conduct follow-up. Any procedures such as these that are outside the realm of usual care are considered study-related and require HSP training.
Why is HSP Training Required of Community Practices?
Participating clinicians and clinic staff require HSP training to ensure their understanding of the ethical obligations under current research regulations. There are differences between usual patient care and research. For example, asking a patient to fill out a medical history and insurance form differs from asking the same person to fill out a research survey on his or her health status, which will be analyzed with other respondent data. The former is required for clinical care and the latter is a voluntary activity. Because clinic staff are often involved in initiating contact with potential participants for a study, they must understand voluntary informed consent and how they can influence or persuade people to participate. Because the clinic staff know the patients personally, the risks to patient privacy and confidentiality and the potential threat of coercion are greater when clinic staff are involved than when non-practice research assistants review records.9
Physicians and staff participating in practice-based research should be aware of how the HIPAA Privacy Rule10 limits the use and disclosure of PHI for research studies. A business associate agreement is one strategy by which PBRN research assistants can access PHI to identify and recruit eligible study participants in situations where the network clinic staff are not able to provide such assistance to the study.11
Can HSP Training be Tailored for Community Practices?
Defining the appropriate level of training for community practices is an important aspect for PBRN researchers to determine when implementing a study protocol.12 In general, training modules should cover the ethical principles of research, informed consent, conflicts of interest, the definitions and consequences of research fraud, and HIPAA constraints on using PHI to identify and recruit eligible patients. Additional modules can be required based on the study protocol; for example, records-based research, studies involving children, or working with investigational drugs or devices.
Many IRBs are ill-informed about the types of low-risk research typically conducted by PBRNs, and initiating a dialogue about how a PBRN′s research may differ from their IRB's typical portfolio can prevent future difficulties. The PBRN administrative group can then consult with their IRB to discuss appropriate training requirements for community practice staff. Often the requirements can be modified for the specific project or community practitioner role. As stated in the PBRN listserv discussion, the American Academy of Family Physicians National Research Network and IRB selected the appropriate level of training for community practices involved in PBRN research, thus reducing the usual Collaborative IRB Training Initiative (CITI)13 course requirements down to 4 modules.14
What Methods are Used for Community Practice HSP Training?
HSP training should be feasible for community practitioners and their staff to complete. Multiple methods have been used by PBRNs based on their ease and convenience. Online training allows asynchronous learning but requires computer and Internet access. Compact discs, digital video discs, videotapes, and paper copies are easier to disseminate and view. Lectures, with slide presentations conducted at the practice during a study start-up meeting or a regional PBRN meeting, are often used to train many personnel in a quick, efficient fashion. IRBs may require completion of courses by the National Institutes of Health (eg, the Office of Clinical Research Training and Medical Education Clinical Research Training Online15), the CITI modules, or institution-developed research ethics modules. A paper version of the online module is helpful for providers and staff who prefer paper-based learning or as referral material for those completing online quizzes at the end of each module. Depending on the modality of training chosen by the PBRN and IRB, completion can take between 1 and 3 hours (Table 2).
Human Subject Protection Training Resources
Reimbursement of community-based clinic staff for the time required for HSP training is highly encouraged. Reimbursement to community practices for training should be added to study budgets at proposal submission. Offering continuing medical education or continuing education unit credits for completing HSP training benefits the practice staff who need to maintain training records for state license renewal, hospital credentialing, or specialty certification. Conducting lectures during lunch hours and offering a meal is an efficient method for practice-based training.
Working With Multiple IRBs
When a PBRN practice membership spans more than one IRB, the requirements from each of the IRBs should be maintained in some fashion, eg, a database to keep track of each institution's training preference.16 Sites that are not affiliated with an IRB should follow the requirements of the IRB that is willing to assume responsibility for their review; unaffiliated investigator agreements often include language that the site will adhere to the policies of the institutional IRB. Some PBRNs formalize these relationships, when possible, by incorporating their network as a not-for-profit entity and covering otherwise unaffiliated practices under a single Federalwide Assurance. Again, opening discussions with the multiple IRBs about the unique nature of PBRNs may result in more streamlined common processes. Regardless, PBRNs should also keep documentation of training completed by community clinicians and staff and know whether annual renewal or recertification is required.
Conclusion
The request for advice on the AHRQ PBRN listserv generated a host of responses from PBRN researchers about the methodology and feasibility of community practice HSP training. Most PBRNs had tailored the training requirements for low-risk PBRN research (eg, surveys, practice improvement, or behavioral interventions) conducted in real-world, non-academic practices. A variety of methods—online, paper, or lecture—are offered to make training easy to complete. Reimbursement for time spent on training is recommended, as well as a discussion with the institutional IRB(s) within a PBRN to define the acceptable strategies for training community-based staff in the areas of HSP most germane to their research involvement.
Acknowledgments
The authors would like to thank Amanda McMillan for her editorial assistance.
Notes
Funding: none.
Conflict of interest: none declared.
- Received for publication May 5, 2008.
- Revision received May 5, 2008.
- Accepted for publication May 8, 2008.
